An interventional study of using biomimetic abutments in Tooth Loss, sponsored by Stomatological Hospital Affiliated with Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Stomatological Hospital Affiliated with Fujian Medical University · Not applicable, Interventional, and Treatment
This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.
The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
To assess soft tissues, digital models were collected in STL files at five time points: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration. These models were analyzed using 3D software for model matching and measurement based on CBCT, focusing on the changes on soft tissue height, width, and volume.
Hard tissue evaluation was conducted through periapical radiographs taken at three time points: immediately after restoration, six months after restoration, and 12 months after restoration.
Additionally, general clinical conditions were assessed at the same three time points, evaluating parameters such as food impaction, plaque index, and gingival index.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Stomatological Hospital Affiliated with Fujian Medical University is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration. Historical or external data from other sources were used as controls to evaluate the treatment efficacy in the experimental group.
Procedure: using biomimetic abutments
The subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
Changes in soft tissue contour
Changes of soft tissue contour in height, width, and volume by matching digital models at different treatment stages.
Time frame: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration
Changes in hard tissue contour
Changes of hard tissue contour in height through periapical radiographs using a long-cone paralleling technique with a film holder.
Time frame: immediately after restoration, six months after restoration, and 12 months after restoration
Food impaction
Incidence of food impaction： Dichotomous registration, 0 = Absent; 1 = Present.
Time frame: immediately after restoration, six months after restoration, and 12 months after restoration
Plaque index
0 = No plaque at the gingival margin; 1 = Thin plaque layer on the gingival margin, not easily visible on inspection but detectable by scraping with a probe; 2 = Moderate plaque accumulation at the gingival margin or interproximal surfaces; 3 = Heavy plaque accumulation in the gingival sulcus, at the gingival margin, or on interproximal surfaces. Mean values among the 6 sites were obtained (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual).
Time frame: immediately after restoration, six months after restoration, and 12 months after restoration
Gingival index
0 = Normal gingiva; 1 = Slight gingival edema, no bleeding on probing; 2 = Gingival edema with bleeding on probing; 3 =Tendency for spontaneous bleeding or presence of ulceration. Mean values among the 6 sites were obtained (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual).
Time frame: immediately after restoration, six months after restoration, and 12 months after restoration
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Sep 2025, 22 months after the start.
Of 71 non-industry interventional studies with no phase under Tooth Loss, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 22 months is below that.
Counting every sponsor, half of 77 studies reached it within 28 months; a quarter within 12 and three quarters within 48.
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Stomatological Hospital Affiliated with Fujian Medical University